MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2

Recruiting now · Not applicable

Conditions studied: Solid Tumor, Leukemia

In brief

FMG2025 continues the previous efforts to propose treatment for patients based on the molecular characteristics of their tumor at treatment failure in cancer precision medicine trials within standard of care in France. However, whereas FMG2025 is a descriptive effort providing the basis for clinical decisions, MAPPYACTS 2 will translate these findings to clinical actions. The symbiosis is critical to advance patient care. Since 2012, the molecular profiling trials "MOlecular Screening for CAncer Treatment Optimization" (MOSCATO-01) and "MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification" (MAPPYACTS) have included pediatric and adolescent patients with recurrent or refractory malignancy that underwent on-purpose biopsy or surgical intervention. Whole Exome Sequencing of tumor and normal tissue and RNA Sequencing of tumor tissue have been applied to detect genomic alterations that could lead to an adapted targeted treatment. Furthermore, ancillary studies were associated exploring circulating tumor DNA, the immune contexture of tumors and developing Patient-Derived Xenografts (PDX). The FMG2025 project transfers the molecular profiling of advanced pediatric cancers into a global approach that is now considered standard of care in France. Subsequent clinical recommendations and decisions will be made based on discussions with biologists, scientist and physicians in the molecular and clinical molecular tumor boards. Associated ancillary research studies and links to clinical interventional studies remain essential elements of the program to provide clinical, translational and basic research in order to improve scientific knowledge. The program is articulated in two main parts that are closely interacting: FMG2025 - Cancers et leucémies pédiatriques en échec de traitement or equivalent international projects that cover the sequencing of tumor and blood samples and provide molecular reports. The clinical study MAPPYACTS 2 that provides clinical and therapeutic discussions of the sequencing results and therapy recommendations via the clinical molecular tumor board reports. It collects molecular and comprehensive clinical data of the patients registered in FMG2025 or equivalent international projects and thereby constitutes the critical link to clinical interventional studies and its sponsors ensuring facilitated access to these trials. It also covers and coordinates ancillary research studies.

Key facts

Study ID

NCT05691608

Run by

Gustave Roussy, Cancer Campus, Grand Paris

People needed

1800

Starts

2022-09-09

Expected to finish

2030-09-09

Last updated by the study team

2025-08-22

Who can join

Age: 6 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patient referred for sequencing of the tumor within the FMG2025 or equivalent program and written informed consent for FMG2025 "Cancers et leucémies pédiatriques en échec de traitement" or equivalent, according to local regulations
• Written informed consent of MAPPYACTS 2 to collect molecular and comprehensive clinical data on cancer diagnosis, therapies, therapy outcomes, to provide clinical therapeutic recommendations, to collect follow-up data on treatment and patients' outcome; optional written consents to perform to ancillary research studies, according to local regulations. The written consent will include access to reimbursement data from the French national health insurance through linkage with the Système National des Données de Santé (SNDS) or equivalent.
• Patient with histologically/cytologically confirmed solid tumor or leukemia which is relapsed or refractory to standard treatment and who is potentially eligible for an experimental treatment or an early phase clinical trial
• Planned tumor biopsy, surgical resection, bone marrow or blood sample or recently (preferably within the last 3 months) archived frozen tumor material available of the current recurrent or refractory disease
• Patients aged ≤ 25 years at the time of initial diagnosis
• Performance status and life expectancy > 3 months expected to allow enrolment into an clinical trial
• Patients affiliated with a Social Security Regimen or beneficiary of the same, as per local regulatory requirements

You may not qualify if…

• Any concurrent illness or laboratory abnormality that, in the opinion of the investigator, is likely to interfere with the interpretation of study results
• Pregnant women

Where it is running

• Gustave Roussy — Paris, Villejuif, France (enrolling)
• CHU Amiens-Picardie — Amiens, France (enrolling)
• CHU Angers — Angers, France (enrolling)
• CHU Besançon — Besançon, France (enrolling)
• CHU Pellegrin — Bordeaux, France (enrolling)
• CHRU Morvan — Brest, France (enrolling)
• CHU de Caen — Caen, France (enrolling)
• CHU Estaing — Clermont-Ferrand, France (enrolling)
• CHU Dijon François Mitterand — Dijon, France (enrolling)
• CHU Grenoble Alpes — Grenoble, France (enrolling)
• Centre Oscar Lambret — Lille, France (enrolling)
• Chu Limoges — Limoges, France (enrolling)
• IHOP — Lyon, France (enrolling)
• CHU La Timone — Marseille, France (enrolling)
• CHU Arnaud de Villeneuve — Montpellier, France (enrolling)
• CHU Nantes — Nantes, France (enrolling)
• CHU de Nice — Nice, France (enrolling)
• Institut Curie — Paris, France (enrolling)
• Hopital Armand Trousseau — Paris, France (enrolling)
• CHU Poitiers — Poitiers, France (enrolling)
• CHU Reims- Hôpital Américain — Reims, France (enrolling)
• CHU Rennes Hôpital Sud — Rennes, France (enrolling)
• CHU de Rouen — Rouen, France (enrolling)
• CHU de La Réunion site nord — Saint-Denis, France (enrolling)
• CHU Saint Etienne — Saint-Etienne, France (enrolling)

Full record on ClinicalTrials.gov

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